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510(k) Data Aggregation

    K Number
    K022843
    Date Cleared
    2002-11-01

    (66 days)

    Product Code
    Regulation Number
    886.4350
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GAYHEART CORNEAL EXCISION DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Trephine made for single use and for the extraction of the cornea.

    Device Description

    A single use ophthalmic device designed to extract the cornea.

    AI/ML Overview

    The Gayheart™ Corncal Excision Device (K022843) is an ophthalmic trephine, a single-use device designed for corneal extraction. Its acceptance criteria and performance were assessed through non-clinical tests demonstrating substantial equivalence to predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Dimensional EquivalencyMeasurements of the Gayheart™ Corneal Excision Device (trephines) were substantially equivalent to the measurements of the predicate devices (Katena, Storz, Rhein, Stephens Ophthalmic Trephines).
    SharpnessSharpness tests (number of cuts and initial cutting sharpness) showed that Stephens trephines perform as well as the predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify the exact sample size for the test set. The tests involved "measurements of the trephines" and "sharpness tests" on the Gayheart™ Corneal Excision Device and a comparison to predicate devices, implying a sufficient number of devices were tested to draw a comparison. The data provenance is not explicitly stated but is implicitly from an internal test by Stephens Instruments as part of their 510(k) submission. This is considered retrospective data from the manufacturer's testing.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    No direct mention of experts or their qualifications for establishing ground truth is provided. The performance tests (dimensional equivalency and sharpness) appear to be objective measurements, likely conducted in a lab setting by technical personnel rather than clinical experts.

    4. Adjudication Method for the Test Set

    No adjudication method is described. The tests were objective measurements (dimensions, sharpness), not subjective interpretations that would require adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No, an MRMC comparative effectiveness study was not done. The device is a Class I ophthalmic trephine, and the submission does not mention any clinical studies or human reader involvement in its evaluation for this 510(k).

    6. If a Standalone (algorithm only without human-in-the-loop performance) was Done

    This question is not applicable. The Gayheart™ Corneal Excision Device is a physical surgical instrument, not an algorithm or AI-powered device. Therefore, the concept of "standalone performance" in the context of AI does not apply.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance claims was based on:

    • Objective Measurements: Directly measured dimensions, number of cuts, and initial cutting sharpness of the devices.
    • Comparison to Predicate Devices: The performance was assessed against established predicate devices, implying that the performance of these legally marketed devices served as the benchmark or "ground truth" for acceptable performance for this type of device.

    8. The Sample Size for the Training Set

    This question is not applicable. The device is a physical surgical instrument and does not involve any artificial intelligence or machine learning algorithms that would require a "training set."

    9. How the Ground Truth for the Training Set Was Established

    This question is not applicable as there is no training set for this device.

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